Boosting the Secretion of GLP-2 and GLP-1 Intestinal Hormones by Nutrients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Nestlé
ClinicalTrials.gov Identifier:
NCT01727583
First received: November 12, 2012
Last updated: November 7, 2013
Last verified: November 2013
  Purpose

This pilot study is aimed at assessing the acute effect of several combinations of lipids differing in their fatty acid composition on glucagon-like-peptide (GLP)-2 and GLP-1 secretion in healthy subjects.


Condition Intervention
Healthy
Dietary Supplement: meal intake
Dietary Supplement: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Boosting the Secretion of GLP-2 and GLP-1 Intestinal Hormones by Nutrients

Further study details as provided by Nestlé:

Primary Outcome Measures:
  • GLP-2 and GLP-1 kinetics [ Time Frame: changes from baseline to 4 hours following meal intake ] [ Designated as safety issue: No ]
    GLP-2 and GLP-1 are measured using Elisa


Secondary Outcome Measures:
  • Intestinal and metabolic hormones [ Time Frame: Changes from baseline to 4 hours following meal intake ] [ Designated as safety issue: No ]
    Those hormones will be measured based on enzymatic technics


Enrollment: 18
Study Start Date: September 2012
Study Completion Date: November 2013
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Lipid 1
Meal intake
Dietary Supplement: meal intake
Intake of meals characterized by lipid composition
Placebo Comparator: Lipid-free
Maltodextrine + proteins
Dietary Supplement: Placebo
Active Comparator: Lipid 2
Meal intake
Dietary Supplement: meal intake
Intake of meals characterized by lipid composition
Active Comparator: Lipid 3
Meal intake
Dietary Supplement: meal intake
Intake of meals characterized by lipid composition
Active Comparator: Lipid 4
meal intake
Dietary Supplement: meal intake
Intake of meals characterized by lipid composition

Detailed Description:

In this study, the investigators aim to investigate the effect of various lipid types on GLP-2 and GLP-1 secretion. This will allow to determine the importance of lipids in nutritional solutions. Moreover, this will allow us to assess whether existing clinical formulas can be improved in order to stimulate GLP-2 and accelerate intestinal recovery.

  Eligibility

Ages Eligible for Study:   20 Years to 40 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • BMI : 19 - 24.9 kg.m-2
  • Normal fasting glycemia
  • Having obtained his informed consent.

Exclusion Criteria:

  • Gastro-intestinal disease (ulcer), pancreatic disease, hepatic disease, metabolic diseases / disorders (diabetes, dyslipidemia), renal disease, cardiovascular disease (arterial hypertension), as determined by the medical screening visit and a blood analysis.
  • Have had a gastrointestinal surgery (with the exception of appendices resection).
  • Malabsorption disorders
  • Lactose intolerance
  • Significant weight loss during the past three months (more than 5% of initial weight)
  • Have a regular consumption of medication
  • Regular supplements (vitamins and minerals) intake during the previous month
  • Have an alcohol intake: > 2 units a day
  • Smoker (more than 2 cigarettes a day)
  • Illicit substances intake, as stated on the medical screening questionnaire
  • Allergy to any food or medication
  • Anaemia defined by a number of erythrocytes or hemoglobin Hb or hematocrit Ht which are inferior to laboratory normal ranges
  • Having given blood in the past three months or willing to give blood in the 3 months following the completion of the study
  • Intense physical activity > 3 hours per week
  • Currently participating or having participated in another clinical trial during the past month.
  • Volunteer who cannot be expected to comply with the protocol, including consuming rapidly the study products, chronic medication intake
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01727583

Locations
Switzerland
Nestlé CDU / Metabolic Unit
Lausanne, Switzerland, 1000
Sponsors and Collaborators
Nestlé
Investigators
Principal Investigator: Maurice Beaumont, MD Nestlé / CDU / Metabolic Unit
  More Information

No publications provided

Responsible Party: Nestlé
ClinicalTrials.gov Identifier: NCT01727583     History of Changes
Other Study ID Numbers: 12.10.MET
Study First Received: November 12, 2012
Last Updated: November 7, 2013
Health Authority: Switzerland: Swissmedic

Keywords provided by Nestlé:
Healthy

ClinicalTrials.gov processed this record on August 19, 2014